PATCH (Preferred Attachment Strategy for Optimal Electrocardiograms)-1 Study

Abstract

12-Lead electrocardiography (ECG) is among the most frequently performed tests in medical practice. Despite its pivotal role in diagnostic and treatment decisions, baseline artifacts and errors in lead placement are common. The PATCH (Preferred Attachment Strategy for Optimal Electrocardiograms)-1 study enrolled patients with stable cardiovascular disease and a clinical indication for an ECG. Each participant underwent both a standard (S) 12-lead ECG and a patch (P) ECG (EKG-Patch™) during one routine ambulatory clinic visit. The P-ECG has an all-in-one design with built-in lead wires attached to pre-positioned electrodes. An experienced clinical research coordinator performed all ECGs. Each was interpreted by an experienced cardiologist blinded to the method of ECG. A total of 200 participants (67.4 ± 14.9 years; range: 21–95 years) (women 44%) had P- and S-ECGs. Common clinical indications included coronary artery disease (40.5%), essential hypertension (14.0%), heart failure (10.5%), atrial fibrillation (10.0%) and valvular heart disease (6.5%). Many participants had more than one indication. The P-ECG provided a tracing in 1.4 ± 0.5 min compared to 2.4 ± 0.5 min with the S-ECG (p < 0.001). Most participants either preferred the P-ECG (47%) or did not have a preference (52%). Baseline artifacts that impacted interpretability were detected in 13 (6.5%) P-ECGs and 30 (15.0%) S-ECGs (p = 0.006). Heart rhythm, rate, conduction, axis, intervals (PR, QRS, QT, and QTc) and ST-T wave findings did not differ between P-and S-ECGs. In conclusion, the P-ECG was preferred among participants, had fewer baseline artifacts than the S-ECG, and provided a rapid and reproducible ECG in patients with stable cardiovascular disease in an ambulatory clinic setting.